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CARPHA Issues its First Emergency Use Recommendation for a COVID-19 Vaccine

CARPHA Issues its First Emergency Use Recommendation for a COVID-19 Vaccine

Port of Spain, Trinidad and Tobago.  8 March 2021.  The CARPHA Caribbean Regulatory System (CRS) issued its first certificate of recommendation for emergency use for the COVID-19 vaccine COVISHIELD™ to CARPHA Member States on 2nd March, 2021.

The decision comes based on the CRS’ review of the product using a regulatory reliance pathway. Reliance is the act where the decisions of a regulatory authority, or trusted institution, are given significant weight in the evaluations performed by another regulatory authority. In this case, the CRS relied on the Emergency Use Listing (EUL) that the World Health Organization (WHO) issued on 15th February 2021 to the ChAdOx1-S [recombinant] vaccine by Serum Institute of India and AstraZeneca-Oxford, called COVISHIELD™.

As a result of a confidentiality agreement signed with WHO, the CRS was able to access the dossier with the data on quality, safety, efficacy, risk management plan (RMP) and programmatic suitability of COVISHIELD™ for CARICOM countries. After a careful review of this information, the CRS issued its recommendation of COVISHIELD™ under the following conditions:

  1. COVISHIELD™ is indicated for active immunization of individuals aged 18 years and older for the prevention of COVID-19.
  2. The recommendation is granted for use only during the pandemic period.
  3. The Serum Institute of India is required to provide to the WHO any missing information and any information related to changes that may affect the quality, efficacy or safety of COVISHIELD.

The review and recommendation made by the CRS are intended to facilitate decision-making for emergency use authorization or import permit, as appropriate, by countries of the Caribbean. It is also expected that the CRS’ report will assist countries to confirm or verify that the product being sourced is the same as the one approved by the WHO. The CRS recommendation is not binding, and governments retain their right to sovereignty in decision-making.

The CRS is an initiative of the Caribbean Community and Common Market (CARICOM) and is managed as a regulatory unit within CARICOM’s regional public health body, the Caribbean Public Health Agency (CARPHA), with support from the Pan American Health Organization and the Bill and Melinda Gates Foundation. To find out more about the CRS and the products it has recommended, visit its website at https://www.carpha.org/What-We-Do/CRS/Caribbean-Regulatory-System

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